Sulfamethoxazole and Trimethoprim

Product NDC
33261-396
11-digit product format
332610396
Labeler code
33261
Product ID
33261-396_a3ab3a35-a130-4804-9ad8-0d733c7a8d48
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA076899
Marketing category
ANDA
Marketing start
2010-02-25
Marketing end
0000-00-00
Substance
SULFAMETHOXAZOLE; TRIMETHOPRIM
Active strength
400 mg/1; mg/1
Pharmacologic classes
Sulfonamide Antimicrobial [EPC],Sulfonamides [CS],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4ce811b5-329e-27f8-b5ff-66d52b435c00Product name320240108
8d30c4f0-0228-cea4-e3aa-f19064c47f27Product name320221128
6e20c430-5e8f-85da-1b03-f7dbc0c51fadProduct name320190926
c1381fd7-868a-f499-ef90-8f6d3e3ee6b3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
33261-396-002020-01-31C16284748780-19d75b9d0-675a-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets and Double Strength Tablets
33261-396-022020-01-31C16284748780-19d75b9d0-675a-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets and Double Strength Tablets
33261-396-062020-01-31C16284748780-19d75b9d0-675a-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets and Double Strength Tablets
33261-396-102020-01-31C16284748780-19d75b9d0-675a-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets and Double Strength Tablets
33261-396-142020-01-31C16284748780-19d75b9d0-675a-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets and Double Strength Tablets
33261-396-202020-01-31C16284748780-19d75b9d0-675a-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets and Double Strength Tablets
33261-396-282020-01-31C16284748780-19d75b9d0-675a-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets and Double Strength Tablets
33261-396-302020-01-31C16284748780-19d75b9d0-675a-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets and Double Strength Tablets
33261-396-402020-01-31C16284748780-19d75b9d0-675a-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets and Double Strength Tablets
33261-396-602020-01-31C16284748780-19d75b9d0-675a-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets and Double Strength Tablets
33261-396-902020-01-31C16284748780-19d75b9d0-675a-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets and Double Strength Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-396-00Sulfamethoxazole and Trimethoprim100 in 1 BOTTLETABLET1001
33261-396-02Sulfamethoxazole and Trimethoprim120 in 1 BOTTLETABLET1201
33261-396-06Sulfamethoxazole and Trimethoprim6 in 1 BOTTLETABLET61
33261-396-10Sulfamethoxazole and Trimethoprim10 in 1 BOTTLETABLET101
33261-396-14Sulfamethoxazole and Trimethoprim14 in 1 BOTTLETABLET141
33261-396-20Sulfamethoxazole and Trimethoprim20 in 1 BOTTLETABLET201
33261-396-28Sulfamethoxazole and Trimethoprim28 in 1 BOTTLETABLET281
33261-396-30Sulfamethoxazole and Trimethoprim30 in 1 BOTTLETABLET301
33261-396-40Sulfamethoxazole and Trimethoprim40 in 1 BOTTLETABLET401
33261-396-60Sulfamethoxazole and Trimethoprim60 in 1 BOTTLETABLET601
33261-396-90Sulfamethoxazole and Trimethoprim90 in 1 BOTTLETABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-396SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 11 package rows20121013_fb9d264a-0536-4517-84f1-2ea2f57658fe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198334sulfamethoxazole 400 MG / trimethoprim 80 MG Oral TabletPSNfb9d264a-0536-4517-84f1-2ea2f57658fe1
198334sulfamethoxazole 400 MG / trimethoprim 80 MG Oral TabletSCDfb9d264a-0536-4517-84f1-2ea2f57658fe1
198334SMX 400 MG / TMP 80 MG Oral TabletSYfb9d264a-0536-4517-84f1-2ea2f57658fe1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-396-0033261039600100 in 1 BOTTLEHistorical
33261-396-0233261039602120 in 1 BOTTLEHistorical
33261-396-06332610396066 in 1 BOTTLEHistorical
33261-396-103326103961010 in 1 BOTTLEHistorical
33261-396-143326103961414 in 1 BOTTLEHistorical
33261-396-203326103962020 in 1 BOTTLEHistorical
33261-396-283326103962828 in 1 BOTTLEHistorical
33261-396-303326103963030 in 1 BOTTLEHistorical
33261-396-403326103964040 in 1 BOTTLEHistorical
33261-396-603326103966060 in 1 BOTTLEHistorical
33261-396-903326103969090 in 1 BOTTLEHistorical